Trial Outcomes & Findings for Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies (NCT NCT01084252)
NCT ID: NCT01084252
Last Updated: 2024-11-01
Results Overview
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
351 participants
Primary outcome timeframe
Day 1 of Cycle 1 up to Day 14 of Cycle 2
Results posted on
2024-11-01
Participant Flow
Study participants were involved in the study from 11 May 2010 at 59 centers in 18 countries. A total of 418 participants were screened, of which 351 participants were enrolled. A total of 67 participants had screen failures due to failure to meet inclusion criteria.
Study consisted 2 phases: Phase 1 and Phase 2. Phase 1 was a dose escalation part of isatuximab to determine maximum tolerated dose (MTD). Phase 2 was conducted for efficacy and safety evaluation of isatuximab with or without dexamethasone. It consisted of 2 stages: Stage 1 (comprised of 1a and 1b) and Stage 2.
Participant milestones
| Measure |
Phase1: Isatuximab <=1 mg/kg Every 2 Weeks (Q2W)
Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (\<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg Every Week (QW)
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20 mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
|
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than \[\<\] 75 years of age; 20 mg/day for greater than or equal to \[\>=\] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 (120 Weeks)
STARTED
|
16
|
6
|
3
|
26
|
18
|
6
|
7
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (120 Weeks)
All Treated (AT) Population
|
16
|
6
|
3
|
26
|
18
|
6
|
7
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (120 Weeks)
COMPLETED
|
16
|
6
|
3
|
26
|
18
|
6
|
7
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 (120 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Stage 1(1a-414Weeks;1b-92Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
24
|
25
|
25
|
0
|
0
|
|
Phase 2 Stage 1(1a-414Weeks;1b-92Weeks)
AT Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
24
|
25
|
25
|
0
|
0
|
|
Phase 2 Stage 1(1a-414Weeks;1b-92Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
24
|
25
|
25
|
0
|
0
|
|
Phase 2 Stage 1(1a-414Weeks;1b-92Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Stage 2 (301 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
110
|
55
|
|
Phase 2 Stage 2 (301 Weeks)
AT Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
109
|
55
|
|
Phase 2 Stage 2 (301 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
109
|
55
|
|
Phase 2 Stage 2 (301 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase1: Isatuximab <=1 mg/kg Every 2 Weeks (Q2W)
Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (\<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg Every Week (QW)
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20 mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
|
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than \[\<\] 75 years of age; 20 mg/day for greater than or equal to \[\>=\] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2 (301 Weeks)
Enrolled, but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=16 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5 mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=26 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
n=18 Participants
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20 mg/kg Q2W
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20 mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
n=23 Participants
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
n=24 Participants
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
n=25 Participants
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
n=25 Participants
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
|
Phase 2 Stage 2: Isatuximab Alone
n=109 Participants
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
Phase 2 Stage 2: Isatuximab + Dexamethasone
n=55 Participants
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than \[\<\] 75 years of age; 20 mg/day for greater than or equal to \[\>=\] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
63.5 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
62.0 years
STANDARD_DEVIATION 3.5 • n=27 Participants
|
65.0 years
STANDARD_DEVIATION 7.2 • n=483 Participants
|
60.8 years
STANDARD_DEVIATION 12.6 • n=36 Participants
|
61.7 years
STANDARD_DEVIATION 12.7 • n=10 Participants
|
63.3 years
STANDARD_DEVIATION 10.0 • n=115 Participants
|
60.0 years
STANDARD_DEVIATION 8.3 • n=40 Participants
|
63.2 years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
63.9 years
STANDARD_DEVIATION 8.8 • n=62 Participants
|
61.0 years
STANDARD_DEVIATION 7.3 • n=95 Participants
|
61.1 years
STANDARD_DEVIATION 10.3 • n=129 Participants
|
66.6 years
STANDARD_DEVIATION 8.8 • n=36 Participants
|
66.3 years
STANDARD_DEVIATION 8.9 • n=36 Participants
|
64.5 years
STANDARD_DEVIATION 9.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
11 Participants
n=8 Participants
|
11 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
13 Participants
n=129 Participants
|
58 Participants
n=36 Participants
|
26 Participants
n=36 Participants
|
162 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
13 Participants
n=62 Participants
|
18 Participants
n=95 Participants
|
12 Participants
n=129 Participants
|
51 Participants
n=36 Participants
|
29 Participants
n=36 Participants
|
188 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
5 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
20 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
21 Participants
n=8 Participants
|
19 Participants
n=62 Participants
|
19 Participants
n=95 Participants
|
21 Participants
n=129 Participants
|
91 Participants
n=36 Participants
|
45 Participants
n=36 Participants
|
287 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
11 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
35 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 1 up to Day 14 of Cycle 2Population: DLT evaluable population included participants who gave their informed consent, received at least 1 dose of isatuximab during Phase 1 and had a DLT assessment at the end of Cycle 2. Data was planned not to be collected and analyzed for the arm: Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma).
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=14 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=6 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )Population: Analysis was performed on AT population which included participants who signed informed consent and received at least 1 dose/even incomplete of isatuximab.
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=16 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=26 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=18 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
16 Participants
|
6 Participants
|
3 Participants
|
26 Participants
|
18 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: From the date of randomization until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for Stage 1b arm)Population: Analysis was performed on AT population which included participants who signed informed consent and received at least 1 dose/even incomplete of isatuximab.
OR defined as participants with stringent complete response (sCR) or complete response (CR) or very good partial response (VGPR) or partial response (PR) . Based on IMWG, CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow; sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; PR: \>=50% reduction of serum M-Protein and reduction in urinary M-protein by \>=90% or to \<200 mg/24 hours; \>=50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a \>=50% reduction in plasma cells in place of M-protein if present at baseline.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=23 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=25 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=25 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria
|
4.3 percentage of participants
|
29.2 percentage of participants
|
20.0 percentage of participants
|
24.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of randomization to date of death from any cause (maximum duration: 97 weeks)Population: Analysis was performed on AT population which included participants who signed informed consent \& received at least 1 dose/even incomplete of isatuximab.
OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours, \>90% decrease in the difference between involved and uninvolved FLC levels; PR: \>=50% reduction of serum M-Protein and reduction in urinary M-protein by \>=90% or to \<200 mg/24 hours; \>=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or \>=50% reduction in plasma cells in place of M-protein if present at baseline.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=109 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=55 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria
|
23.9 percentage of participants
|
43.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusionPopulation: Here, "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "0" in "number analyzed" field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms "Phase 1: Isatuximab 10mg/kg QW" and "Phase 1: Isatuximab 20mg/kg QW" was planned to be collected and analyzed.
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab \<=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=4 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=2 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=15 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=5 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=3 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=4 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)
Cycle 1 Day 1
|
2.08667 microgram per milliliter (mcg/mL)
Standard Deviation 0.65567
|
13.18333 microgram per milliliter (mcg/mL)
Standard Deviation 5.74464
|
44.22500 microgram per milliliter (mcg/mL)
Standard Deviation 15.30651
|
125.50000 microgram per milliliter (mcg/mL)
Standard Deviation 53.03301
|
171.43333 microgram per milliliter (mcg/mL)
Standard Deviation 50.18853
|
148.80000 microgram per milliliter (mcg/mL)
Standard Deviation 18.48513
|
400.33333 microgram per milliliter (mcg/mL)
Standard Deviation 52.51984
|
173.33333 microgram per milliliter (mcg/mL)
Standard Deviation 20.64784
|
334.33333 microgram per milliliter (mcg/mL)
Standard Deviation 98.28462
|
|
Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
299.82500 microgram per milliliter (mcg/mL)
Standard Deviation 220.83898
|
715.33333 microgram per milliliter (mcg/mL)
Standard Deviation 188.01241
|
SECONDARY outcome
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusionPopulation: Here, "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "0" in "number analyzed" field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms "Phase 1: Isatuximab 10mg/kg QW" and "Phase 1: Isatuximab 20mg/kg QW" was planned to be collected and analyzed.
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab \<=1mg/kg in participant flow). Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=4 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=2 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=11 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=5 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=3 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=4 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab
Cycle 1 Day 1
|
2.00 mcg/mL
Geometric Coefficient of Variation 31
|
12.4 mcg/mL
Geometric Coefficient of Variation 45
|
53.7 mcg/mL
Geometric Coefficient of Variation 28
|
126 mcg/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation was not calculated because it was pre-specified not to calculate the value if number of participants was \<=2.
|
181 mcg/mL
Geometric Coefficient of Variation 48
|
154 mcg/mL
Geometric Coefficient of Variation 13
|
457 mcg/mL
Geometric Coefficient of Variation 28
|
181 mcg/mL
Geometric Coefficient of Variation 20
|
343 mcg/mL
Geometric Coefficient of Variation 29
|
|
PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
265 mcg/mL
Geometric Coefficient of Variation 67
|
712 mcg/mL
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusionPopulation: Here, "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "0" in "number analyzed" field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms "Phase 1: Isatuximab 10mg/kg QW" and "Phase 1: Isatuximab 20mg/kg QW" was planned to be collected and analyzed.
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab \<=1mg/kg in participant flow). Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=4 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=2 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=11 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=5 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=3 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=4 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab
Cycle 1 Day 1
|
2.49 hours
Interval 1.42 to 3.43
|
4.35 hours
Interval 3.13 to 6.33
|
6.99 hours
Interval 4.58 to 8.0
|
7.65 hours
Interval 5.13 to 10.17
|
4.28 hours
Interval 2.15 to 9.37
|
4.92 hours
Interval 2.6 to 30.08
|
5.87 hours
Interval 5.78 to 9.9
|
2.25 hours
Interval 2.2 to 7.5
|
6.83 hours
Interval 3.98 to 10.53
|
|
PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.30 hours
Interval 2.57 to 27.48
|
8.07 hours
Interval 2.87 to 29.03
|
SECONDARY outcome
Timeframe: Week 1, 2 and 3Population: Analysis was performed on PK population. Here, 'number analyzed' = number of participants with available data for each category.
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab \<=1mg/kg in participant flow).
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=18 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=16 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3
Week 2
|
0.000800 mcg/mL
Geometric Coefficient of Variation 173
|
0.181 mcg/mL
Geometric Coefficient of Variation 136
|
1.39 mcg/mL
Geometric Coefficient of Variation 116
|
1.97 mcg/mL
Geometric Coefficient of Variation 145
|
8.31 mcg/mL
Geometric Coefficient of Variation 77
|
55.1 mcg/mL
Geometric Coefficient of Variation 63
|
63.9 mcg/mL
Geometric Coefficient of Variation 46
|
194.8 mcg/mL
Geometric Coefficient of Variation 36
|
—
|
|
PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3
Week 1
|
0.00223 mcg/mL
Geometric Coefficient of Variation 86
|
1.44 mcg/mL
Geometric Coefficient of Variation 85
|
15.3 mcg/mL
Geometric Coefficient of Variation 90
|
27.6 mcg/mL
Geometric Coefficient of Variation 81
|
44.2 mcg/mL
Geometric Coefficient of Variation 52
|
20.7 mcg/mL
Geometric Coefficient of Variation 63
|
113 mcg/mL
Geometric Coefficient of Variation 37
|
108 mcg/mL
Geometric Coefficient of Variation 33
|
—
|
|
PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3
Week 3
|
0.000283 mcg/mL
Geometric Coefficient of Variation 145
|
0.460 mcg/mL
Geometric Coefficient of Variation 121
|
42.7 mcg/mL
Geometric Coefficient of Variation 73
|
4.18 mcg/mL
Geometric Coefficient of Variation 133
|
18.6 mcg/mL
Geometric Coefficient of Variation 71
|
75.9 mcg/mL
Geometric Coefficient of Variation 78
|
91.0 mcg/mL
Geometric Coefficient of Variation 52
|
347.3 mcg/mL
Geometric Coefficient of Variation 36
|
—
|
SECONDARY outcome
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusionPopulation: Analysis was performed on PK population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab \<=1mg/kg in participant flow).
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=18 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=16 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W)
|
222 mcg*hour/mL
Geometric Coefficient of Variation 80
|
2624 mcg*hour/mL
Geometric Coefficient of Variation 24
|
7174 mcg*hour/mL
Geometric Coefficient of Variation 54
|
11566 mcg*hour/mL
Geometric Coefficient of Variation 48
|
13480 mcg*hour/mL
Geometric Coefficient of Variation 38
|
12680 mcg*hour/mL
Geometric Coefficient of Variation 35
|
32739 mcg*hour/mL
Geometric Coefficient of Variation 28
|
28405 mcg*hour/mL
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 336 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 336 hr post-infusionPopulation: Analysis was performed on PK population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab \<=1mg/kg in participant flow).
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=18 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=16 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First 2 Weeks (0-336 Hours) (AUC2W)
|
222 mcg*hour/mL
Geometric Coefficient of Variation 80
|
3076 mcg*hour/mL
Geometric Coefficient of Variation 35
|
9546 mcg*hour/mL
Geometric Coefficient of Variation 70
|
14876 mcg*hour/mL
Geometric Coefficient of Variation 64
|
18967 mcg*hour/mL
Geometric Coefficient of Variation 44
|
30187 mcg*hour/mL
Geometric Coefficient of Variation 40
|
48003 mcg*hour/mL
Geometric Coefficient of Variation 31
|
71174 mcg*hour/mL
Geometric Coefficient of Variation 29
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Analysis was performed on all randomized participants who gave their informed consent, had received at least 1 dose (even incomplete) of isatuximab and had an assessable PD parameter. Here, 'number analyzed' = number of participants with available data for each category.
Serum/plasma markers included: tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1-β), interleukin 6 (IL-6) and interferon-gamma (IFN-Gamma). Due to change in planned analysis, data for high-sensitivity C-reactive protein (hs-CRP) and CD38 was not collected and analyzed.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=16 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=26 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=18 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
TNF alpha
|
163.181 picogram/milliliter (pg/mL)
Standard Deviation 253.373
|
179.783 picogram/milliliter (pg/mL)
Standard Deviation 191.455
|
352.974 picogram/milliliter (pg/mL)
Standard Deviation 220.394
|
340.799 picogram/milliliter (pg/mL)
Standard Deviation 341.100
|
503.462 picogram/milliliter (pg/mL)
Standard Deviation 479.813
|
342.664 picogram/milliliter (pg/mL)
Standard Deviation 410.245
|
307.319 picogram/milliliter (pg/mL)
Standard Deviation 398.025
|
412.541 picogram/milliliter (pg/mL)
Standard Deviation 243.169
|
—
|
|
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
IL-1 Beta
|
64.577 picogram/milliliter (pg/mL)
Standard Deviation 227.399
|
29.741 picogram/milliliter (pg/mL)
Standard Deviation 55.515
|
7.527 picogram/milliliter (pg/mL)
Standard Deviation 8.118
|
299.058 picogram/milliliter (pg/mL)
Standard Deviation 572.260
|
547.770 picogram/milliliter (pg/mL)
Standard Deviation 1454.175
|
327.957 picogram/milliliter (pg/mL)
Standard Deviation 759.305
|
305.914 picogram/milliliter (pg/mL)
Standard Deviation 621.754
|
293.307 picogram/milliliter (pg/mL)
Standard Deviation 612.746
|
—
|
|
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
IL-6
|
139.234 picogram/milliliter (pg/mL)
Standard Deviation 212.385
|
261.732 picogram/milliliter (pg/mL)
Standard Deviation 270.119
|
73.899 picogram/milliliter (pg/mL)
Standard Deviation 53.211
|
148.594 picogram/milliliter (pg/mL)
Standard Deviation 175.719
|
173.004 picogram/milliliter (pg/mL)
Standard Deviation 433.297
|
-8.109 picogram/milliliter (pg/mL)
Standard Deviation 45.845
|
274.616 picogram/milliliter (pg/mL)
Standard Deviation 234.752
|
165.295 picogram/milliliter (pg/mL)
Standard Deviation 203.451
|
—
|
|
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
IFN Gamma
|
477.116 picogram/milliliter (pg/mL)
Standard Deviation 1673.063
|
5.376 picogram/milliliter (pg/mL)
Standard Deviation 9.312
|
25.806 picogram/milliliter (pg/mL)
Standard Deviation 44.698
|
445.772 picogram/milliliter (pg/mL)
Standard Deviation 1043.982
|
568.806 picogram/milliliter (pg/mL)
Standard Deviation 1022.000
|
627.089 picogram/milliliter (pg/mL)
Standard Deviation 1527.647
|
448.387 picogram/milliliter (pg/mL)
Standard Deviation 569.499
|
1487.097 picogram/milliliter (pg/mL)
Standard Deviation 2693.826
|
—
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Analysis was performed on ADA evaluable population which included all treated participants with at least one ADA assessment with a reportable result during the ADA on-study observation period.
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 1) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=16 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=26 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=18 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response
Treatment boosted ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response
Treatment-induced ADA
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)Population: Analysis was performed on all-treated population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
OR defined as participants with complete response (CR) or partial response (PR) as best overall response (BOR). Clinical benefit: participants with minimal response (MR) or better as BOR. BOR: best sequential response from start of treatment through the entire study excluding any time point following start of other treatment. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow aspirates, no increase in size or number of lytic bone lesions. PR: \>=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by \>=90% or \<200mg, \>=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. MR: 25 to 49% reduction in serum M-protein, 50-89% reduction in 24h urine M-protein, 25-49% reduction in size of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=5 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=25 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=18 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=6 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria
OR
|
33.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
28.0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
14.3 percentage of participants
|
28.6 percentage of participants
|
—
|
|
Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria
Clinical benefit
|
33.3 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
28.0 percentage of participants
|
27.8 percentage of participants
|
33.3 percentage of participants
|
28.6 percentage of participants
|
42.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From the date of first response to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)Population: Analysis was performed only on subset of participants who had response in Phase 1 and not for the reporting group with no response.
DOR: time from first response (PR or better) to first documented tumor progression/death. Progression as per EBMT: \>25% increase in serum monoclonal paraprotein level, which must also be an absolute increase of \>= 5 g/l: confirmed by \>=1 repeated investigation; \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of \>=200 mg/24 h:confirmed by \>=1 repeated investigation; \>25% increase in plasma cells in a bone marrow aspirate/on trephine biopsy, which must also be an absolute increase of \>= 10%; definite increase in size of existing bone lesions/soft tissue plasmacytomas; development of new bone lesions/soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \>11·5 mg/dl or 2·8 mmol/l) not attributable to any other cause. PR: \>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by \>=90% or \<200mg, \>=50% reduction in size/number of soft tissue plasmacytomas, no increase in size/number of lytic bone lesions.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=7 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=3 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=2 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=2 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Assessment: Phase 1: Duration of Response (DOR)
|
20.21 months
|
7.16 months
|
5.76 months
Standard Deviation 4.62
|
10.70 months
Standard Deviation 11.25
|
14.31 months
Standard Deviation 7.50
|
3.94 months
|
8.82 months
Standard Deviation 7.83
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose administration to the date of first response or death (due to any cause) (maximum duration: 120 weeks)Population: Analysis was performed only on subset of participants who had response in Phase 1 and not for the reporting group with no response.
TTR was defined as the time from first dose of isatuximab to first response (PR or better). PR: \>=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by \>=90% or \<200mg, \>=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=7 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=3 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
n=2 Participants
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=2 Participants
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Assessment: Phase 1: Time to First Response (TTR)
|
0.95 months
|
6.41 months
|
2.52 months
Standard Deviation 3.77
|
1.96 months
Standard Deviation 1.72
|
1.38 months
Standard Deviation 0.65
|
1.18 months
|
1.46 months
Standard Deviation 0.77
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, during treatment (Day 1 up to 120 weeks)Population: Analysis was performed on AT population. Data for this outcome measure was planned to be collected and analyzed for a combined arm of overall Phase 1 AT population.
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest \<50% of waking hours; 3=Bed rest/sitting \>50% of waking hours; 4=Bedridden or unable to care for self, where lower score indicated good performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the best values (categorized as: Baseline ECOG 1, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 1) are reported.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=89 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment
Baseline ECOG 1, During Treatment ECOG 0
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment
Baseline ECOG 2, During Treatment ECOG 0
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment
Baseline ECOG 2, During Treatment ECOG 1
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, during treatment (up to 120 weeks)Population: Analysis was performed on AT population. Data for this outcome measure was planned to be collected and analyzed for a combined arm of overall Phase 1 AT population.
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest \<50% of waking hours; 3=Bed rest/sitting\>50% of waking hours; 4=Bedridden or unable to care for self, where higher score indicated worst performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the worst values (categorized as: Baseline ECOG 0, During Treatment ECOG 1; Baseline ECOG 2, During Treatment ECOG 1; Baseline ECOG 0, During Treatment ECOG 2; Baseline ECOG 1, During Treatment ECOG 2; Baseline ECOG 0, During Treatment ECOG 3; Baseline ECOG 1, During Treatment ECOG 3; Baseline ECOG 2, During Treatment ECOG 3) are reported.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=89 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 0, During Treatment ECOG 1
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 2, During Treatment ECOG 1
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 0, During Treatment ECOG 2
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 1, During Treatment ECOG 2
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 0, During Treatment ECOG 3
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 1, During Treatment ECOG 3
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
Baseline ECOG 2, During Treatment ECOG 3
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 414 weeks for Stage 1a and 92 weeks for Stage 1b)Population: Analysis was performed on AT population which included Participants who signed informed consent \& received at least 1 dose/even incomplete of isatuximab.
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=23 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=25 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=25 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
22 Participants
|
24 Participants
|
25 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 301 weeks)Population: Analysis was performed on AT population which included participants who signed informed consent \& received at least 1 dose/even incomplete of isatuximab.
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=109 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=55 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
101 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first response until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed only on subset of population who had response in Phase 2 stage 1.
DOR:Time from date of 1st IAC determined response (\>= PR) that was subsequently confirmed, to date of first IAC determined PD/death, whichever happened earlier. updated IMWG criteria- PR:\>=50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or a \>=50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a \>=50% reduction in size of soft tissue plasmacytomas; PD: Increase of 25% from lowest response value in any of following: Serum M-protein \>=0.5 g/dL absolute increase and/or urine M-protein \>=200 mg/24 hours absolute increase and/or \>10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, \>=10% bone marrow plasma cells (PCs), development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium \>11·5 mg/dl) attributed to PC proliferation disorder.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=1 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=7 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=5 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=6 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Duration of Response
|
1.91 months
|
11.17 months
Standard Deviation 5.77
|
7.31 months
Standard Deviation 3.65
|
8.11 months
Standard Deviation 2.33
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first response until disease progression or death or data cut-off (maximum duration: 97 weeks)Population: Analysis was performed only on subset of population who had response in Phase 2 stage 2.
DOR: Time from date of 1st IAC determined response (\>= PR) that was subsequently confirmed, to date of 1st IAC determined PD or death, whichever happened earlier. As per updated IMWG criteria-PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. ≥50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline ≥50% reduction in size of soft tissue plasmacytomas; PD: Increase of \>25% from lowest response value in any one of following: Serum M-component (absolute increase must be \>0.5 g/dL)4 and/or Urine M-component (absolute increase must be \>200 mg/24 h) and/or \>10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, \>=10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to plasma cell proliferative disorder.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=26 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2: Duration of Response
|
8.6 months
Standard Deviation 5.2
|
10.9 months
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first documentation of progression or death (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed on AT population.
Clinical benefit: participants with sCR, CR, VGPR, PR or MR as per IMWG criteria, determined by IAC. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytomas,\<5% PCs in bone marrow aspirates. sCR: CR + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum \& urine M-component detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-component plus urine M-component level \<100mg/24hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours, ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline, ≥50% size reduction in soft tissue plasmacytomas. MR:\>=25 but \<49% reduction in serum M-protein, reduction in 24h urine M-protein by 50-89%, 25-49% size reduction in soft tissue plasmacytomas.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=23 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=25 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=25 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Percentage of Participants With Clinical Benefit
|
4.3 percentage of participants
|
41.7 percentage of participants
|
32.0 percentage of participants
|
36.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first documentation of progression or death (maximum duration: 97 weeks )Population: Analysis was performed on AT population.
Clinical benefit:participants with sCR, CR, VGPR, PR or MR, per IMWG criteria, determined by IAC. CR:negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates,normal FLC ratio(0.26-1.65) in participants with only FLC disease.sCR:CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy.VGPR:serum \& urine M-component detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-component plus urine M-component level \<100mg/24h/,\>=90% decrease in difference between involved and uninvolved FLC levels; PR:\>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by \>=90%/\<200mg/24h,\>50% decrease in difference between involved and uninvolved FLC in place of M-protein criteria, \>=50% reduction in size/number of soft tissue plasmacytomas. MR:\>=25 but \<49% reduction in serum M-protein,reduction in 24h urine M-protein by 50-89%, 25-49% reduction in size of soft tissue plasmacytomas
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=109 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=55 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2: Percentage of Participants With Clinical Benefit
|
43.1 percentage of participants
|
54.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed on AT population.
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression (PD) or date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of \> 25% from lowest response value in any one or more of the following: 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 h), \> 10mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, \>10% absolute percentage of bone marrow plasma cell, 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 attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=23 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=25 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=25 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Progression Free Survival (PFS)
|
2.1 months
Interval 1.02 to 5.49
|
9.6 months
Interval 2.23 to
Upper limit of confidence interval was not estimable due to less number of participants with event.
|
4.4 months
Interval 1.84 to 5.82
|
3.6 months
Interval 1.91 to 9.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 97 weeks)Population: Analysis was performed on AT population.
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression or the date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of \>25% from lowest response value in any one of the following: Serum M-component (the absolute increase must be \>0.5 g/dL)4 and/or Urine M-component (the absolute increase must be \>200 mg/24 h) and/or \>10 mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, ≥10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=109 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=55 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2: Progression Free Survival
|
4.86 months
Interval 3.877 to 7.688
|
10.15 months
Interval 4.862 to 17.347
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to date of death from any cause (maximum duration 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed on AT population.
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=23 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=25 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=25 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Overall Survival (OS)
|
15.277 months
Interval 4.731 to
Upper limit of Confidence Interval (CI) was not estimable, due to less number of participants with event.
|
18.628 months
Interval 7.7536 to 20.1068
|
NA months
Interval 8.4435 to
Median and upper limit of CI was not estimable, due to less number of participants with event.
|
NA months
Interval 8.345 to
Median and upper limit of CI was not estimable, due to less number of participants with event.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to date of death from any cause (maximum duration: 97 weeks)Population: Analysis was performed on AT population.
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=109 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=55 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 2: Overall Survival
|
18.92 months
Interval 13.602 to 23.064
|
17.25 months
Interval 15.409 to
Upper limit of CI was not estimable, due to less number of participants with event.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and End of Treatment (EOT: anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed on AT population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category.
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) \& other single items. For each item, high score = high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health \& quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 \& 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=22 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=21 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=24 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=22 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 2 day 1
|
-8.33 score on a scale
Standard Deviation 20.15
|
2.22 score on a scale
Standard Deviation 16.51
|
-3.95 score on a scale
Standard Deviation 20.67
|
0.00 score on a scale
Standard Deviation 15.39
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 3 day 1
|
0.00 score on a scale
Standard Deviation 19.25
|
-0.76 score on a scale
Standard Deviation 16.44
|
6.55 score on a scale
Standard Deviation 19.66
|
-2.08 score on a scale
Standard Deviation 15.54
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 4 day 1
|
0.00 score on a scale
Standard Deviation 24.53
|
-5.30 score on a scale
Standard Deviation 21.50
|
6.06 score on a scale
Standard Deviation 21.11
|
7.41 score on a scale
Standard Deviation 8.78
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 5 day 1
|
0.00 score on a scale
Standard Deviation 24.53
|
0.69 score on a scale
Standard Deviation 15.27
|
6.48 score on a scale
Standard Deviation 21.15
|
5.00 score on a scale
Standard Deviation 4.56
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 6 day 1
|
12.50 score on a scale
Standard Deviation 14.43
|
-10.19 score on a scale
Standard Deviation 25.27
|
5.95 score on a scale
Standard Deviation 13.36
|
10.42 score on a scale
Standard Deviation 7.98
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 7 day 1
|
12.50 score on a scale
Standard Deviation 5.89
|
-3.57 score on a scale
Standard Deviation 15.85
|
8.33 score on a scale
Standard Deviation 11.79
|
6.67 score on a scale
Standard Deviation 6.97
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 8 day 1
|
0.00 score on a scale
Standard Deviation 35.36
|
-11.11 score on a scale
Standard Deviation 18.76
|
4.17 score on a scale
Standard Deviation 15.96
|
6.25 score on a scale
Standard Deviation 10.49
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 9 day 1
|
-8.33 score on a scale
Standard Deviation 11.79
|
-10.00 score on a scale
Standard Deviation 19.90
|
4.17 score on a scale
Standard Deviation 14.43
|
6.25 score on a scale
Standard Deviation 10.49
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
Cycle 10 day 1
|
-8.33 score on a scale
Standard Deviation 35.36
|
-16.67 score on a scale
Standard Deviation 22.05
|
8.33 score on a scale
Standard Deviation 11.79
|
3.33 score on a scale
Standard Deviation 7.45
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
End of treatment
|
3.33 score on a scale
Standard Deviation 33.64
|
-11.67 score on a scale
Standard Deviation 13.94
|
-11.11 score on a scale
Standard Deviation 20.97
|
-12.50 score on a scale
Standard Deviation 5.89
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed on AT population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category.
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with MM. It has 4 subscales: body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). Disease symptoms subscale used 4-point scale ranged from 1= 'Not at All' to 4= 'Very Much'. Scores were averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=22 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=21 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=23 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=22 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 6 day 1
|
8.33 score on a scale
Standard Deviation 7.17
|
1.23 score on a scale
Standard Deviation 23.53
|
-15.08 score on a scale
Standard Deviation 20.96
|
-6.94 score on a scale
Standard Deviation 10.52
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 7 day 1
|
2.78 score on a scale
Standard Deviation 3.93
|
-3.70 score on a scale
Standard Deviation 22.95
|
-18.06 score on a scale
Standard Deviation 21.93
|
-11.11 score on a scale
Standard Deviation 11.79
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 8 day 1
|
-5.56 score on a scale
Standard Deviation 7.86
|
-2.78 score on a scale
Standard Deviation 23.50
|
-15.28 score on a scale
Standard Deviation 23.30
|
-4.17 score on a scale
Standard Deviation 5.32
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 9 day 1
|
5.56 score on a scale
Standard Deviation 7.86
|
-10.00 score on a scale
Standard Deviation 10.69
|
-16.67 score on a scale
Standard Deviation 29.75
|
-6.94 score on a scale
Standard Deviation 12.32
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 10 day 1
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 19.25
|
-15.28 score on a scale
Standard Deviation 30.56
|
-6.67 score on a scale
Standard Deviation 17.30
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
End of treatment
|
-9.72 score on a scale
Standard Deviation 19.44
|
7.78 score on a scale
Standard Deviation 24.41
|
24.07 score on a scale
Standard Deviation 22.45
|
25.00 score on a scale
Standard Deviation 35.36
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 2 day 1
|
5.56 score on a scale
Standard Deviation 18.36
|
-3.42 score on a scale
Standard Deviation 11.24
|
0.93 score on a scale
Standard Deviation 13.91
|
2.61 score on a scale
Standard Deviation 18.75
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 3 day 1
|
7.94 score on a scale
Standard Deviation 11.94
|
-5.05 score on a scale
Standard Deviation 14.15
|
-5.98 score on a scale
Standard Deviation 16.89
|
-1.52 score on a scale
Standard Deviation 13.17
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 4 day 1
|
8.33 score on a scale
Standard Deviation 13.22
|
-3.89 score on a scale
Standard Deviation 16.98
|
-10.00 score on a scale
Standard Deviation 16.93
|
0.62 score on a scale
Standard Deviation 30.10
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
Cycle 5 day 1
|
-6.94 score on a scale
Standard Deviation 10.52
|
0.51 score on a scale
Standard Deviation 19.95
|
-9.03 score on a scale
Standard Deviation 17.04
|
-6.67 score on a scale
Standard Deviation 17.74
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)Population: Analysis was performed on AT population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category.
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=22 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=21 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=22 Participants
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=22 Participants
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
Cycle 4 day 1
|
-5.75 score on a scale
Standard Deviation 18.55
|
2.00 score on a scale
Standard Deviation 16.88
|
-4.78 score on a scale
Standard Deviation 15.71
|
4.89 score on a scale
Standard Deviation 16.02
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
Cycle 7 day 1
|
-2.50 score on a scale
Standard Deviation 0.71
|
-6.00 score on a scale
Standard Deviation 27.39
|
9.00 score on a scale
Standard Deviation 18.25
|
1.00 score on a scale
Standard Deviation 7.94
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
Cycle 10 day 1
|
0.50 score on a scale
Standard Deviation 2.12
|
-10.33 score on a scale
Standard Deviation 9.29
|
10.33 score on a scale
Standard Deviation 24.38
|
-2.60 score on a scale
Standard Deviation 8.11
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
Cycle 13 day 1
|
14.00 score on a scale
Standard Deviation 19.80
|
-5.00 score on a scale
Standard Deviation 4.00
|
-9.00 score on a scale
|
-5.00 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
Cycle 16 day 1
|
5.00 score on a scale
Standard Deviation 5.66
|
0.67 score on a scale
Standard Deviation 23.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
Cycle 19 day 1
|
—
|
-5.50 score on a scale
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
End of treatment
|
-18.50 score on a scale
Standard Deviation 16.98
|
-11.60 score on a scale
Standard Deviation 11.37
|
-10.00 score on a scale
Standard Deviation 9.54
|
-9.00 score on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, at the end of infusion, 1 hour and 168 hours post dose on Day 1 of Cycle 1Population: Analysis was performed on PK population which included participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=102 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=52 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 1 Week Interval
|
37096 mcg*hour/mL
Geometric Coefficient of Variation 80
|
35423 mcg*hour/mL
Geometric Coefficient of Variation 88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: pre-dose, at the end of infusion, 168 and 336 hours post-infusionPopulation: Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=102 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=52 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 2 Weeks Interval
|
91271 mcg*hour/mL
Geometric Coefficient of Variation 78
|
86761 mcg*hour/mL
Geometric Coefficient of Variation 77
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: pre-dose, at the end of infusion, 168, 336, and 672 hours post-infusionPopulation: Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=102 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=52 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 4 Weeks Interval
|
236360 mcg*hour/mL
Geometric Coefficient of Variation 72
|
226372 mcg*hour/mL
Geometric Coefficient of Variation 66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 7, 14 and 28Population: Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=102 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=52 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)
Day 7
|
137 mcg/mL
Geometric Coefficient of Variation 75
|
128 mcg/mL
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)
Day 14
|
230 mcg/mL
Geometric Coefficient of Variation 70
|
214 mcg/mL
Geometric Coefficient of Variation 57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)
Day 28
|
360 mcg/mL
Geometric Coefficient of Variation 63
|
305 mcg/mL
Geometric Coefficient of Variation 66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2, Day 1; Cycle 1, Day 8; Cycle 4, Day 1Population: Analysis was performed on PK population. Here, 'number of participants analyzed' = participants evaluable for this outcome measure.
Ctrough is the plasma concentration observed before treatment administration. For 1st category, the accumulation ratio was calculated by dividing Ctrough value of Cycle 2 Day 1 by Cycle 1 Day 8 and for second category, accumulation ratio was calculated by dividing Ctrough value of Cycle 4 Day 1 by Cycle 1 Day 8.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=95 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=48 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough
Cycle 2 Day 1/Cycle 1 Day 8
|
521.38338 ratio
Standard Deviation 4891.63390
|
3.24370 ratio
Standard Deviation 1.73860
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough
Cycle 4 Day 1/Cycle 1 Day 8
|
3.58378 ratio
Standard Deviation 2.77398
|
3.95950 ratio
Standard Deviation 3.19310
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 97 weeksPopulation: Analysis was performed on ADA evaluable population which included all treated participants with at least one ADA assessment with a reportable result during the ADA on-study observation period.
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 2 Stage 2) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.
Outcome measures
| Measure |
Phase 1:Isatuximab <=1 mg/kg Q2W
n=107 Participants
Participants with CD38+ HM, received Isatuximab at any one of the dose \<= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=53 Participants
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab
Treatment induced ADA
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab
Treatment boosted ADA
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Isatuximab <=1 mg/kg Q2W
Serious events: 3 serious events
Other events: 16 other events
Deaths: 5 deaths
Phase 1: Isatuximab 3mg/kg Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1: Isatuximab 5mg/kg Q2W
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Serious events: 10 serious events
Other events: 26 other events
Deaths: 0 deaths
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Serious events: 10 serious events
Other events: 18 other events
Deaths: 2 deaths
Phase 1: Isatuximab 10mg/kg QW
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1: Isatuximab 20mg/kg Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1: Isatuximab 20mg/kg QW
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Serious events: 13 serious events
Other events: 22 other events
Deaths: 11 deaths
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Serious events: 11 serious events
Other events: 23 other events
Deaths: 13 deaths
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Serious events: 10 serious events
Other events: 25 other events
Deaths: 11 deaths
Phase 2 Stage 1b: Isatuximab 20 mg/kg QW and Then Q2W
Serious events: 9 serious events
Other events: 24 other events
Deaths: 11 deaths
Phase 2 Stage 2: Isatuximab Alone
Serious events: 52 serious events
Other events: 92 other events
Deaths: 56 deaths
Phase 2 Stage 2: Isatuximab + Dexamethasone
Serious events: 27 serious events
Other events: 47 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Phase 1: Isatuximab <=1 mg/kg Q2W
n=16 participants at risk
Participants with CD38+ HM, received Isatuximab at any one of the dose \<=1 mg/kg (i.e. either 0.0001 mg/kg or 0.001mg/kg or 0.01mg/kg or 0.03mg/kg, or 0.1mg/kg or 0.3 mg/kg or 1 mg/kg as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 participants at risk
Participants with CD38+HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 participants at risk
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=26 participants at risk
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
n=18 participants at risk
Participants with CD38+ HM along with participants with high risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10mg/kg QW
n=6 participants at risk
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=7 participants at risk
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 participants at risk
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
n=23 participants at risk
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
n=24 participants at risk
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
n=25 participants at risk
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1b: Isatuximab 20 mg/kg QW and Then Q2W
n=25 participants at risk
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Day 1 of each 28-days cycle until Unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
|
Phase 2 Stage 2: Isatuximab Alone
n=109 participants at risk
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
Phase 2 Stage 2: Isatuximab + Dexamethasone
n=55 participants at risk
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion tablet or as IV infusion (40 mg/day for \<75 years of age; 20 mg/day for \>=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Blood and lymphatic system disorders
Hyperviscosity Syndrome
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Endocrine disorders
Hypercalcaemia Of Malignancy
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Cataract
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Eye Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Gastrointestinal Amyloidosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Mechanical Ileus
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Asthenia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Chills
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Disease Progression
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
4/23 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
6.4%
7/109 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Fatigue
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Feeling Cold
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Malaise
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Performance Status Decreased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Physical Deconditioning
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Sudden Death
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Abdominal Sepsis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Haemophilus Sepsis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Infectious Colitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Infective Aortitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Meningitis Bacterial
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Meningococcal Sepsis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumococcal Bacteraemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
15.4%
4/26 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
8/109 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.1%
5/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
4/23 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Varicella
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Varicella Zoster Virus Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
6/109 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Leukaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of The Oral Cavity
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Product Issues
Device Malfunction
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Product Issues
Device Occlusion
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea At Rest
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Swelling
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Alkalosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Haemorrhage
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Social circumstances
Loss Of Personal Independence In Daily Activities
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Extrinsic Iliac Vein Compression
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
Other adverse events
| Measure |
Phase 1: Isatuximab <=1 mg/kg Q2W
n=16 participants at risk
Participants with CD38+ HM, received Isatuximab at any one of the dose \<=1 mg/kg (i.e. either 0.0001 mg/kg or 0.001mg/kg or 0.01mg/kg or 0.03mg/kg, or 0.1mg/kg or 0.3 mg/kg or 1 mg/kg as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 3mg/kg Q2W
n=6 participants at risk
Participants with CD38+HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 5mg/kg Q2W
n=3 participants at risk
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
n=26 participants at risk
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
n=18 participants at risk
Participants with CD38+ HM along with participants with high risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 10mg/kg QW
n=6 participants at risk
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg Q2W
n=7 participants at risk
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 1: Isatuximab 20mg/kg QW
n=7 participants at risk
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
|
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
n=23 participants at risk
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
n=24 participants at risk
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
n=25 participants at risk
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
|
Phase 2 Stage 1b: Isatuximab 20 mg/kg QW and Then Q2W
n=25 participants at risk
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Day 1 of each 28-days cycle until Unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
|
Phase 2 Stage 2: Isatuximab Alone
n=109 participants at risk
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
Phase 2 Stage 2: Isatuximab + Dexamethasone
n=55 participants at risk
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion tablet or as IV infusion (40 mg/day for \<75 years of age; 20 mg/day for \>=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
6/16 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
38.5%
10/26 • Number of events 13 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
22.2%
4/18 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
39.1%
9/23 • Number of events 14 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
32.0%
8/25 • Number of events 11 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
32.0%
8/25 • Number of events 12 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
24.0%
6/25 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Bradycardia
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Right Ventricular Hypertrophy
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Diplopia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Dry Eye
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Scleral Discolouration
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Vision Blurred
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
15.4%
4/26 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
6.4%
7/109 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
26.1%
6/23 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
10.1%
11/109 • Number of events 13 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
3/16 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
23.1%
6/26 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
22.2%
4/18 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
21.7%
5/23 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
29.2%
7/24 • Number of events 13 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
36.0%
9/25 • Number of events 11 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.0%
5/25 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
21.1%
23/109 • Number of events 37 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.0%
11/55 • Number of events 17 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.1%
5/55 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Glossodynia
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
38.5%
10/26 • Number of events 13 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
6/18 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
66.7%
4/6 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
26.1%
6/23 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
37.5%
9/24 • Number of events 14 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
44.0%
11/25 • Number of events 16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.0%
7/25 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.7%
16/109 • Number of events 18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.7%
7/55 • Number of events 32 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
23.1%
6/26 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
22.2%
4/18 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.0%
7/25 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
24.0%
6/25 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.9%
13/109 • Number of events 15 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Asthenia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
15.4%
4/26 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
8/109 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.7%
7/55 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Chest Discomfort
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
24.0%
6/25 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Chills
|
25.0%
4/16 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.8%
5/24 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
32.0%
8/25 • Number of events 12 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
9/109 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Face Oedema
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Fatigue
|
50.0%
8/16 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
30.8%
8/26 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
27.8%
5/18 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
66.7%
4/6 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
57.1%
4/7 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
21.7%
5/23 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
29.2%
7/24 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
44.0%
11/25 • Number of events 12 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
36.0%
9/25 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.5%
18/109 • Number of events 106 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.0%
11/55 • Number of events 17 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Feeling Hot
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Implant Site Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Influenza Like Illness
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Injection Site Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Oedema Peripheral
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.8%
5/24 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.1%
5/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
General disorders
Pyrexia
|
25.0%
4/16 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
19.2%
5/26 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.8%
5/24 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.7%
7/55 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Immune system disorders
Cytokine Release Syndrome
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Angular Cheilitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
6/109 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Herpes Simplex
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.7%
7/55 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Otitis Media
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Pyuria
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Respiratory Tract Infection
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.2%
1/16 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
26.9%
7/26 • Number of events 11 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
50.0%
3/6 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
42.9%
3/7 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
4/23 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
29.2%
7/24 • Number of events 17 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
36.0%
9/25 • Number of events 20 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
24.0%
6/25 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.8%
14/109 • Number of events 16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.5%
8/55 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
8/109 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
2/16 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
31.2%
5/16 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
50.0%
3/6 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
46.2%
12/26 • Number of events 12 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
55.6%
10/18 • Number of events 13 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
66.7%
4/6 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
57.1%
4/7 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
42.9%
3/7 • Number of events 74 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
39.1%
9/23 • Number of events 11 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
54.2%
13/24 • Number of events 17 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
56.0%
14/25 • Number of events 14 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
60.0%
15/25 • Number of events 16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
34.9%
38/109 • Number of events 41 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
36.4%
20/55 • Number of events 21 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Scapula Fracture
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Injury, poisoning and procedural complications
Sports Injury
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Blood Creatinine Increased
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Carbon Monoxide Diffusing Capacity Decreased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Lymphocyte Count Decreased
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
21.7%
5/23 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Qrs Axis Abnormal
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Investigations
Weight Decreased
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
19.2%
5/26 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
4/23 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.0%
5/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
10.1%
11/109 • Number of events 11 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Metabolism and nutrition disorders
Pseudohyponatraemia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.8%
5/24 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.0%
5/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.0%
12/109 • Number of events 15 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.1%
5/55 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
23.1%
6/26 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
38.9%
7/18 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
29.2%
7/24 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
18.3%
20/109 • Number of events 23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.4%
9/55 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
15.4%
4/26 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.2%
10/109 • Number of events 12 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
9/109 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.1%
5/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
8/109 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
8/109 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
18.2%
10/55 • Number of events 13 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Balance Disorder
|
6.2%
1/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Cranial Nerve Paralysis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Head Discomfort
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
19.2%
5/26 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 33 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
4/23 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.8%
5/24 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.0%
7/25 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.0%
7/25 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.8%
15/109 • Number of events 22 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.5%
8/55 • Number of events 9 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
9.1%
5/55 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Nervous system disorders
Vith Nerve Paralysis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Abnormal Dreams
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.7%
4/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Bradyphrenia
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
25.0%
6/24 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
25.5%
14/55 • Number of events 19 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Irritability
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Reproductive system and breast disorders
Nipple Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Reproductive system and breast disorders
Vulvovaginal Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
2/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
23.1%
6/26 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
50.0%
3/6 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.7%
2/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
41.7%
10/24 • Number of events 14 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.0%
7/25 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
32.0%
8/25 • Number of events 11 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
19/109 • Number of events 22 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
21.8%
12/55 • Number of events 16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
15.4%
4/26 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
27.8%
5/18 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
42.9%
3/7 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
21.7%
5/23 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.8%
5/24 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
32.0%
8/25 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
15.6%
17/109 • Number of events 19 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.7%
7/55 • Number of events 7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.5%
3/26 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
6/109 • Number of events 6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Discomfort
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
9/109 • Number of events 10 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
4/24 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.5%
3/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
3/18 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
2/109 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Lesion
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Tightness
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Stenosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
20.0%
5/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Hair Texture Abnormal
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.5%
3/55 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.7%
2/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.6%
2/55 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
14.3%
1/7 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Flushing
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
28.6%
2/7 • Number of events 39 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
17.4%
4/23 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.2%
1/24 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
12.0%
3/25 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.0%
4/25 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.0%
2/25 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
2.8%
3/109 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
3.8%
1/26 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
11.1%
2/18 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
16.7%
1/6 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 8 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.92%
1/109 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
7.3%
4/55 • Number of events 4 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/18 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
13.0%
3/23 • Number of events 3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
8.3%
2/24 • Number of events 2 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.6%
5/109 • Number of events 5 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
1.8%
1/55 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Pallor
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.3%
1/23 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
|
Vascular disorders
Peripheral Coldness
|
0.00%
0/16 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/3 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/26 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
5.6%
1/18 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/6 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/7 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/23 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/24 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
4.0%
1/25 • Number of events 1 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/25 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/109 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
0.00%
0/55 • All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER