Trial Outcomes & Findings for Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (NCT NCT04251533)
NCT ID: NCT04251533
Last Updated: 2026-02-13
Results Overview
PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
Results posted on
2026-02-13
Participant Flow
Participant milestones
| Measure |
Part A: Alpelisib + Nab-paclitaxel
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxel
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
35
|
|
Overall Study
COMPLETED
|
8
|
14
|
4
|
|
Overall Study
NOT COMPLETED
|
44
|
36
|
31
|
Reasons for withdrawal
| Measure |
Part A: Alpelisib + Nab-paclitaxel
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxel
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Study
Progressive disease
|
33
|
29
|
22
|
|
Overall Study
Death
|
5
|
1
|
3
|
|
Overall Study
Physician Decision
|
3
|
2
|
4
|
|
Overall Study
Participant decision
|
1
|
3
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
Baseline Characteristics
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
Baseline characteristics by cohort
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=52 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=50 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxel
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.76 • n=6 Participants
|
59.1 years
STANDARD_DEVIATION 11.34 • n=6 Participants
|
48.4 years
STANDARD_DEVIATION 12.21 • n=12 Participants
|
55.5 years
STANDARD_DEVIATION 11.74 • n=1267 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=6 Participants
|
49 Participants
n=6 Participants
|
35 Participants
n=12 Participants
|
136 Participants
n=1267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=1267 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
23 Participants
n=12 Participants
|
85 Participants
n=1267 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
10 Participants
n=12 Participants
|
46 Participants
n=1267 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=1267 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=1267 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=1267 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=1267 Participants
|
PRIMARY outcome
Timeframe: Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 monthsPopulation: Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.
PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=52 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=50 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
|
7.2 months
Interval 3.71 to 8.57
|
5.6 months
Interval 3.75 to 12.68
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Part B1: The full analysis set included all participants to whom study treatment was assigned.
ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1
|
14.3 percentage of participants
Interval 4.8 to 30.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 66 monthsOverall survival is defined as the time from date of randomization to date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 monthsPopulation: Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.
ORR with confirmed response was the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=52 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=50 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Response Rate (ORR) With Confirmed Response in Study Part A
|
40.4 percentage of participants
Interval 27.0 to 54.9
|
34.0 percentage of participants
Interval 21.2 to 48.8
|
—
|
SECONDARY outcome
Timeframe: Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 monthsPopulation: Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.
Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=52 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=50 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR) With Confirmed Response in Study Part A
|
50.0 percentage of participants
Interval 35.8 to 64.2
|
44.0 percentage of participants
Interval 30.0 to 58.7
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Part B1: The full analysis set included all participants to whom study treatment was assigned.
Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B1
|
25.7 percentage of participants
Interval 12.5 to 43.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 monthsPopulation: Part A: The full analysis set included all participants to whom study treatment was assigned by randomization.
Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=52 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=50 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Time to Response (TTR) in Study Part A
|
NA months
Interval 4.14 to
The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
NA months
The median and lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Part B1: The full analysis set included all participants to whom study treatment was assigned.
Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Time to Response (TTR) in Study Part B1
|
NA months
The median and lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 monthsPopulation: Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. Results are reported for participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR).
Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=21 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=17 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Duration of Response (DOR) With Confirmed Response in Study Part A
|
7.39 months
Interval 5.59 to 9.53
|
NA months
Interval 10.55 to
The median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 20 monthsPopulation: Part B1: The full analysis set included all participants to whom study treatment was assigned. Results are reported for participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR).
Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=5 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Duration of Response (DOR) With Confirmed Response in Study Part B1
|
11.04 months
Interval 7.46 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 26 months.Population: Part B1: All participants to whom study treatment was assigned.
Overall survival for Part B1 was defined as the number of participants who were alive at the end of the post-treatment period.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Overall Survival in Study Part B1
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Part B1: The full analysis set included all participants to whom study treatment was assigned.
PFS was defined as time from the date of enrolment to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1
|
3.71 months
Interval 3.15 to 5.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 monthsPopulation: Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. Results are reported for participants with available data.
PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=27 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=22 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Study Part A
|
7.5 months
Interval 3.58 to 9.17
|
3.5 months
Interval 1.77 to 5.85
|
—
|
SECONDARY outcome
Timeframe: On-treatment deaths: Up to approximately 28 months (Part A) or approximately 17 months (Part B1). Post-treatment survival follow-up deaths: Up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1).Population: Parts A and B: All participants to whom study treatment was assigned.
On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.
Outcome measures
| Measure |
Part A: Alpelisib + Nab-paclitaxel
n=52 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxel
n=50 Participants
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
n=35 Participants
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|
|
Post-Hoc: All Collected Deaths
On-treatment deaths
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Post-Hoc: All Collected Deaths
Post-treatment survival follow-up deaths
|
19 Participants
|
14 Participants
|
11 Participants
|
|
Post-Hoc: All Collected Deaths
All deaths
|
25 Participants
|
20 Participants
|
14 Participants
|
Adverse Events
Part A: Alpelisib + Nab-paclitaxelEdit
Serious events: 22 serious events
Other events: 51 other events
Deaths: 6 deaths
Part A: Placebo + Nab-paclitaxelEdit
Serious events: 15 serious events
Other events: 47 other events
Deaths: 6 deaths
Part B1: Alpelisib + Nab-paclitaxelEdit
Serious events: 14 serious events
Other events: 34 other events
Deaths: 3 deaths
Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths
Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Part A: Alpelisib + Nab-paclitaxelEdit
n=52 participants at risk
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxelEdit
n=50 participants at risk
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
n=35 participants at risk
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Eye disorders
Cataract
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Asthenia
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Chills
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Fatigue
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
General physical health deterioration
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Oedema peripheral
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Pain
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Appendicitis perforated
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
COVID-19
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Device related infection
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood creatinine increased
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Weight decreased
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
Other adverse events
| Measure |
Part A: Alpelisib + Nab-paclitaxelEdit
n=52 participants at risk
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Placebo + Nab-paclitaxelEdit
n=50 participants at risk
Participants received placebo + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part B1: Alpelisib + Nab-paclitaxelEdit
n=35 participants at risk
Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle.
|
Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
48.1%
25/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
44.0%
22/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
31.4%
11/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.2%
10/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
6/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.2%
10/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
26.0%
13/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
22.9%
8/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
13.5%
7/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
6/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
20.0%
7/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
63.5%
33/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
22.0%
11/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
60.0%
21/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
20/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
24.0%
12/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
48.6%
17/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
13/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
20.0%
7/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
13/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
6/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Asthenia
|
17.3%
9/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
10.0%
5/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Fatigue
|
23.1%
12/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
20.0%
10/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
25.7%
9/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Malaise
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Mucosal inflammation
|
9.6%
5/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Oedema peripheral
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
16.0%
8/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Peripheral swelling
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
13.5%
7/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
10.0%
5/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
COVID-19
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
22.0%
11/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Paronychia
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
5/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
4/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
13.5%
7/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
17.3%
9/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
16.0%
8/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood creatinine increased
|
11.5%
6/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood insulin increased
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
17.3%
9/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
18.0%
9/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Lipase increased
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Neutrophil count decreased
|
21.2%
11/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
24.0%
12/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Platelet count decreased
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Weight decreased
|
46.2%
24/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
10.0%
5/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
37.1%
13/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
White blood cell count decreased
|
23.1%
12/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
18.0%
9/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
13/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
10.0%
5/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
20.0%
7/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
73.1%
38/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
16.0%
8/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
54.3%
19/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.1%
12/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
18.0%
9/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
6/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.0%
7/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
6/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Dizziness
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
4/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.4%
4/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
4/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Lethargy
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
6/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Polyneuropathy
|
1.9%
1/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
3/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Taste disorder
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Psychiatric disorders
Insomnia
|
5.8%
3/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
6/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Reproductive system and breast disorders
Breast pain
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
4/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.3%
9/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.0%
7/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
2/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.6%
5/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.9%
1/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
13/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
28.0%
14/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
22.9%
8/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
4/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.5%
6/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
10.0%
5/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.3%
5/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
13/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
26.0%
13/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.6%
3/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.6%
5/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Vascular disorders
Hypertension
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
1/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Vascular disorders
Lymphoedema
|
3.8%
2/52 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/50 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.7%
2/35 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
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0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
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0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER