Trial Outcomes & Findings for Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies (NCT NCT04418661)
NCT ID: NCT04418661
Last Updated: 2025-05-29
Results Overview
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
From first dose of IMP up to 30 days after the last dose; approximately 27 weeks
Results posted on
2025-05-29
Participant Flow
The study was conducted at 20 centers in 7 countries. A total of 95 participants were screened (Part 1: 24; Part 2: 47; Part 3A: 1; Part 4: 23) between 09 June 2020 and 22 December 2022, of which 30 were screen failures.
The study was conducted in 4 parts (Part 1, 2, 3 and 4), Part 3 was divided into Part 3A and 3B, of which Part 3B was not initiated and no participants were enrolled. The study was terminated due to strategic reasons not related to safety.
Participant milestones
| Measure |
Part 1- SAR442720 140 mg BIW + Pembrolizumab
Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)
Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)\>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
13
|
13
|
19
|
1
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
13
|
12
|
18
|
1
|
15
|
Reasons for withdrawal
| Measure |
Part 1- SAR442720 140 mg BIW + Pembrolizumab
Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)
Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)\>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 4- SAR442720 200mg + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
5
|
3
|
0
|
2
|
|
Overall Study
Progressive disease
|
4
|
11
|
6
|
11
|
1
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)
n=13 Participants
Participants with PD-L1 TPS\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
n=19 Participants
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
n=1 Participants
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 4- SAR442720 200mg + Pembrolizumab
n=15 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
From 18 to 64 years
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
|
Age, Customized
From 65 to 74 years
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Age, Customized
75 years and over
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
39 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
47 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From first dose of IMP up to 30 days after the last dose; approximately 27 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
4 Participants
|
13 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: DLT evaluable population consisted of participants who took at least 4 of the 6 planned doses of SAR442720 (Part-1 and Part-3A) and 28 of the 42 planned doses of adagrasib (Part-3A) in the first cycle of the treatment and completed the DLT observation period OR participants who had any DLT observed in the DLT observation period.
Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)\>= 4 AEs, G3 neutropenia lasting \>7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G\>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist \>5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by \>15 days, in the absence of recovery to baseline or G \<=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=12 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
n=1 Participants
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=19 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Objective Response Rate (ORR)
|
23.1 percentage of participants
Interval 6.6 to 49.5
|
5.3 percentage of participants
Interval 0.3 to 22.6
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of IMP up to 30 days after the last dose; approximately 7 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=1 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
TEAEs
|
1 Participants
|
—
|
—
|
—
|
|
Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
TESAEs
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)Population: PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=15 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
24 hours post-dose: C1 D1
|
272 nanogram per milliter (ng/mL)
Standard Deviation 94.9
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Pre-dose: C1 D1
|
0 nanogram per milliter (ng/mL)
Standard Deviation 0
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
0.5 hours post-dose: C1 D1
|
207 nanogram per milliter (ng/mL)
Standard Deviation 376
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
1 hours post-dose: C1 D1
|
262 nanogram per milliter (ng/mL)
Standard Deviation 323
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
2 hours post-dose: C1 D1
|
342 nanogram per milliter (ng/mL)
Standard Deviation 324
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
4 hours post-dose: C1 D1
|
488 nanogram per milliter (ng/mL)
Standard Deviation 200
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
8 hours post-dose: C1 D1
|
492 nanogram per milliter (ng/mL)
Standard Deviation 220
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Pre-dose: C1 D8
|
36.5 nanogram per milliter (ng/mL)
Standard Deviation 23.6
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Pre-dose: C1 D15
|
8.67 nanogram per milliter (ng/mL)
Standard Deviation 21.6
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
0.5 hours post-dose: C1 D15
|
458 nanogram per milliter (ng/mL)
Standard Deviation 524
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
1 hours post-dose: C1 D15
|
629 nanogram per milliter (ng/mL)
Standard Deviation 615
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
2 hours post-dose: C1 D15
|
757 nanogram per milliter (ng/mL)
Standard Deviation 441
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
4 hours post-dose: C1 D15
|
649 nanogram per milliter (ng/mL)
Standard Deviation 267
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
8 hours post-dose: C1 D15
|
540 nanogram per milliter (ng/mL)
Standard Deviation 226
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
24 hours post-dose: C1 D15
|
342 nanogram per milliter (ng/mL)
Standard Deviation 127
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Pre-dose: C2 D1
|
7.50 nanogram per milliter (ng/mL)
Standard Deviation 16.7
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
0.5 hours post-dose: C2 D1
|
238 nanogram per milliter (ng/mL)
Standard Deviation 454
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
1 hours post-dose: C2 D1
|
408 nanogram per milliter (ng/mL)
Standard Deviation 414
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
2 hours post-dose: C2 D1
|
557 nanogram per milliter (ng/mL)
Standard Deviation 341
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
4 hours post-dose: C2 D1
|
583 nanogram per milliter (ng/mL)
Standard Deviation 254
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
8 hours post-dose: C2 D1
|
463 nanogram per milliter (ng/mL)
Standard Deviation 168
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
24 hours post-dose: C2 D1
|
288 nanogram per milliter (ng/mL)
Standard Deviation 118
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Pre-dose: C6 D1
|
21.3 nanogram per milliter (ng/mL)
Standard Deviation 21.8
|
—
|
—
|
—
|
|
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
End of treatment (Week 45)
|
54.3 nanogram per milliter (ng/mL)
Standard Deviation 42.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1Population: PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.
Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=9 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
C1 D1 (Tablet/Fed)
|
9410 hour*ng/mL
Standard Deviation 3310
|
—
|
—
|
—
|
|
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
C1 D15 (Tablet/Fasted)
|
10800 hour*ng/mL
Standard Deviation 4290
|
—
|
—
|
—
|
|
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
C2D1 (Capsules/Fasted)
|
9800 hour*ng/mL
Standard Deviation 3970
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1Population: PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.
Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=9 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
C1D1 (Tablet/Fed)
|
637 ng/mL
Standard Deviation 220
|
—
|
—
|
—
|
|
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
C1D15 (Tablet/Fasted)
|
828 ng/mL
Standard Deviation 310
|
—
|
—
|
—
|
|
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
C2D1 (Capsules/Fasted)
|
658 ng/mL
Standard Deviation 326
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1Population: PK evaluable population consisted of participants who completed all of C1 and C2D1 with meal information, full PK, and no dose reduction/missed doses on C1D1, C1D15 and C2D1.
Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=9 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
C1D1 (Tablet/Fed)
|
3.75 hour
Interval 1.08 to 24.0
|
—
|
—
|
—
|
|
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
C1D15 (Tablet/Fasted)
|
2.02 hour
Interval 0.9 to 7.58
|
—
|
—
|
—
|
|
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
C2D1 (Capsules/Fasted)
|
3.6 hour
Interval 0.93 to 24.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)Population: PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=12 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 1: Plasma Concentration of SAR442720
Pre-dose: C1 D1
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
2 hours post-dose: C1 D1
|
332 ng/mL
Standard Deviation 208
|
519 ng/mL
Standard Deviation 270
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
8 hours post-dose: C1 D1
|
327 ng/mL
Standard Deviation 91.0
|
335 ng/mL
Standard Deviation 91.0
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
Pre-dose: C1 D8
|
—
|
42.5 ng/mL
Standard Deviation 50.4
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
Pre-dose: C1 D15
|
267 ng/mL
Standard Deviation 328
|
37.1 ng/mL
Standard Deviation 25.7
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
Pre-dose: C2 D1
|
29.4 ng/mL
Standard Deviation 5.40
|
29.6 ng/mL
Standard Deviation 24.8
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
2 hours post-dose: C2 D1
|
516 ng/mL
Standard Deviation 145
|
527 ng/mL
Standard Deviation 337
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
8 hours post-dose: C2 D1
|
413 ng/mL
Standard Deviation 118
|
409 ng/mL
Standard Deviation 205
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
2 hours post-dose: C2 D2
|
—
|
698 ng/mL
Standard Deviation 350
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
Pre-dose: C6 D1
|
—
|
75.9 ng/mL
Standard Deviation NA
Standard deviation (SD) cannot be calculated for a single participant.
|
—
|
—
|
|
Part 1: Plasma Concentration of SAR442720
End of treatment (Week 22)
|
39.0 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
221 ng/mL
Standard Deviation 334
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)Population: PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=12 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=18 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Plasma Concentration of SAR442720
Pre-dose: C1 D1
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
2 hours post-dose: C1 D1
|
325 ng/mL
Standard Deviation 202
|
385 ng/mL
Standard Deviation 285
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
Pre-dose: C1 D8
|
106 ng/mL
Standard Deviation 154
|
100 ng/mL
Standard Deviation 172
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
Pre-dose: C1 D15
|
149 ng/mL
Standard Deviation 234
|
85.1 ng/mL
Standard Deviation 81.4
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
Pre-dose: C2 D1
|
53.3 ng/mL
Standard Deviation 50.8
|
83.9 ng/mL
Standard Deviation 159
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
2 hours post-dose: C2 D1
|
340 ng/mL
Standard Deviation 211
|
442 ng/mL
Standard Deviation 369
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
Pre-dose: C6 D1
|
94.9 ng/mL
Standard Deviation 42.8
|
50.1 ng/mL
Standard Deviation 16.8
|
—
|
—
|
|
Part 2: Plasma Concentration of SAR442720
End of treatment (Week 104)
|
22.3 ng/mL
Standard Deviation 39.0
|
19.0 ng/mL
Standard Deviation 33.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1Population: PK population consisted of participants who had at least 1 measurable pembrolizumab concentration after the first dose. Only those participants with data collected at specified timepoints are reported.
Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=10 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
n=11 Participants
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
n=16 Participants
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Parts 1 and 2: Serum Concentration of Pembrolizumab
Pre-dose: C1 D1
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Parts 1 and 2: Serum Concentration of Pembrolizumab
Post-dose: C1 D1
|
83200 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
63600 ng/mL
Standard Deviation 11600
|
85200 ng/mL
Standard Deviation 38100
|
98900 ng/mL
Standard Deviation 55500
|
|
Parts 1 and 2: Serum Concentration of Pembrolizumab
Pre-dose: C2 D1
|
15500 ng/mL
Standard Deviation 5350
|
14400 ng/mL
Standard Deviation 5480
|
10800 ng/mL
Standard Deviation 3520
|
9290 ng/mL
Standard Deviation 3620
|
|
Parts 1 and 2: Serum Concentration of Pembrolizumab
Pre-dose: C6 D1
|
—
|
46000 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
23400 ng/mL
Standard Deviation 6450
|
27200 ng/mL
Standard Deviation 6350
|
SECONDARY outcome
Timeframe: Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)Population: Safety population consisted of participants who took at least 1 dose of any IMP.
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
n=15 Participants
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Parts 1 and 4: Percentage of Participants With Objective Response Rate
|
0 percentage of participants
Interval 0.0 to 52.7
|
0 percentage of participants
Interval 0.0 to 20.6
|
6.7 percentage of participants
Interval 0.3 to 27.9
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP and with best overall response (BOR) at least PR. Only responders with BOR with at least a PR were included in the analysis.
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=3 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=1 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Duration of Response
|
NA months
NA indicates that the median, upper limit, and lower limit of CI were not estimable due to insufficient number of participants with events.
|
16.59 months
NA indicates upper and lower limit of 90% CI was not estimable when only 1 participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of IMP up to 30 days after the last dose; approximately 111 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=19 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
TEAEs
|
13 Participants
|
18 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
TESAEs
|
9 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of IMP up to 30 days after the last dose; approximately 50 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=15 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
TEAEs
|
15 Participants
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
TESAEs
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.
TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=3 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=1 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Time to Response (TTR)
|
2.23 months
Interval 2.103 to
NA indicates that the upper limit of CI was not estimable due to insufficient number of participants with events.
|
4.34 months
NA indicates upper and lower limit of 90% CI was not estimable when only 1 participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=19 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Clinical Benefit Rate
|
30.8 percentage of participants
Interval 11.3 to 57.3
|
21.1 percentage of participants
Interval 7.5 to 41.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=19 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Disease Control Rate
|
53.8 percentage of participants
Interval 28.7 to 77.6
|
31.6 percentage of participants
Interval 14.7 to 53.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=13 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=19 Participants
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 2: Progression Free Survival (PFS)
|
3.38 months
Interval 1.084 to 7.852
|
1.95 months
Interval 1.117 to 6.111
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)Population: PK population consisted of participants who had at least 1 measurable SAR442720 concentration after the first dose.
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=1 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 3A: Plasma Concentration of SAR442720
0.5 hours post-dose: C1 D1
|
0 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
1 hours post-dose: C1 D1
|
0 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
2 hours post-dose: C1 D1
|
170 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
4 hours post-dose: C1 D1
|
432 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
6 hours post-dose: C1 D1
|
356 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
24 hours post-dose: C1 D1
|
167 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
Pre-dose: C1 D8
|
31.5 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
Pre-dose: C1 D15
|
36.6 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
0.5 hours post-dose: C1 D15
|
34.3 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
1 hours post-dose: C1 D15
|
46.6 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
2 hours post-dose: C1 D15
|
306 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
4 hours post-dose: C1 D15
|
376 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
6 hours post-dose: C1 D15
|
310 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
End of treatment (Week 3)
|
0 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of SAR442720
Pre-dose: C1 D1
|
0 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8 post-dose C1D1 and C1D15; pre-dose C1D8Population: PK population consisted of participants who had at least 1 measurable adagrasib concentration after the first dose.
Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=1 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 3A: Plasma Concentration of Adagrasib
Pre-dose: C1 D1
|
0 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
1 hours post-dose: C1 D1
|
376 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
2 hours post-dose: C1 D1
|
727 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
4 hours post-dose: C1 D1
|
1560 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
6 hours post-dose: C1 D1
|
1330 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
8 hours post-dose: C1 D1
|
1180 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
Pre-dose: C1 D8
|
2640 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
Pre-dose: C1 D15
|
2110 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
1 hours post-dose: C1 D15
|
2150 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
2 hours post-dose: C1 D15
|
2910 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
4 hours post-dose: C1 D15
|
2880 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
6 hours post-dose: C1 D15
|
2510 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
|
Part 3A: Plasma Concentration of Adagrasib
8 hours post-dose: C1 D15
|
2320 ng/mL
Standard Deviation NA
SD cannot be calculated for a single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed till end of treatment, approximately 3 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP.
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Outcome measures
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=1 Participants
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|
|
Part 3A: Percentage of Participants With Objective Response Rate
|
0 percentage of participants
Interval 0.0 to 95.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed till end of treatment, approximately 3 weeksPopulation: Safety population consisted of participants who took at least 1 dose of any IMP and with BOR at least PR. Only responders with BOR with at least a PR were included in the analysis.
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Outcome measures
Outcome data not reported
Adverse Events
Part 1- SAR442720 140mg BIW + Pembrolizumab
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Part 1- SAR442720 200mg BIW + Pembrolizumab
Serious events: 7 serious events
Other events: 13 other events
Deaths: 6 deaths
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)
Serious events: 9 serious events
Other events: 12 other events
Deaths: 5 deaths
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
Serious events: 11 serious events
Other events: 16 other events
Deaths: 11 deaths
Part 3A- SAR442720 100mg BIW + Adagrasib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 4- SAR442720 200mg + Pembrolizumab
Serious events: 7 serious events
Other events: 14 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 participants at risk
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=13 participants at risk
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)
n=13 participants at risk
Participants with PD-L1 TPS\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
n=19 participants at risk
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
n=1 participants at risk
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 4- SAR442720 200mg + Pembrolizumab
n=15 participants at risk
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Disease Progression
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Sudden Death
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Cytomegalovirus Colitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
30.8%
4/13 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary Tumour Thrombotic Microangiopathy
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Central Nervous System Lesion
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Transverse Sinus Thrombosis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea At Rest
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
Other adverse events
| Measure |
Part 1- SAR442720 140mg BIW + Pembrolizumab
n=4 participants at risk
Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 1- SAR442720 200mg BIW + Pembrolizumab
n=13 participants at risk
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%)
n=13 participants at risk
Participants with PD-L1 TPS\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%)
n=19 participants at risk
Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 3A- SAR442720 100mg BIW + Adagrasib
n=1 participants at risk
Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
Part 4- SAR442720 200mg + Pembrolizumab
n=15 participants at risk
Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
46.2%
6/13 • Number of events 6 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
26.3%
5/19 • Number of events 7 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
20.0%
3/15 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 6 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Dry Eye
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Eyelid Irritation
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
30.8%
4/13 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
30.8%
4/13 • Number of events 6 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
26.3%
5/19 • Number of events 8 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
33.3%
5/15 • Number of events 5 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
20.0%
3/15 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Chest Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Face Oedema
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
20.0%
3/15 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Feeling Cold
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Generalised Oedema
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Oedema
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
21.1%
4/19 • Number of events 8 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
20.0%
3/15 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Swelling
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
General disorders
Temperature Intolerance
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Covid-19
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
25.0%
1/4 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Aspartate Aminotransferase Increased
|
50.0%
2/4 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
30.8%
4/13 • Number of events 6 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
38.5%
5/13 • Number of events 5 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
50.0%
2/4 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
75.0%
3/4 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 5 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Blood Fibrinogen Decreased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Blood Potassium Decreased
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
100.0%
1/1 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
International Normalised Ratio
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Lipase Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 10 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Transaminases Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Troponin Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Weight Decreased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Investigations
Weight Increased
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.8%
3/19 • Number of events 5 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
26.3%
5/19 • Number of events 7 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
100.0%
1/1 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
23.1%
3/13 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
21.1%
4/19 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
20.0%
3/15 • Number of events 3 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Haemorrhage
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
10.5%
2/19 • Number of events 4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
5.3%
1/19 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
13.3%
2/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
7.7%
1/13 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/15 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
15.4%
2/13 • Number of events 2 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/13 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/19 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
0.00%
0/1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
6.7%
1/15 • Number of events 1 • Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Analysis was performed on safety population.
|
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